Sr. Associate, Quality Assurance

Kincell is seeking a highly motivated Senior Associate who will be a key contributor to a dynamic and collaborative Quality Assurance team.

The Senior Associate, Quality Assurance supports the day-to-day early phase cell and gene therapy clinical GMP manufacturing operations via execution of all operational elements of the Quality Management System (QMS), including but not limited to the EDMS (electronic document management system) and training management system in support of gene and cell therapy manufacturing production. They will collaborate cross-functionally with Manufacturing, Supply Chain, Facilities, and the Laboratories to ensure cGMP compliance and establish a quality culture. This is a unique opportunity to help build and grow the Quality Assurance organization in a new dynamic environment. Experience with administrative access using Veeva as a document control and training management system preferred.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

Essential Duties and Responsibilities

• Work with Quality team members to develop, implement, and maintain a phase appropriate Quality Management System (QMS) through the creation, review, and approval of documentation including policies and standard operating procedures (SOPs). Primary focus will be on cGXP operations.
• Partner with Manufacturing, Quality Control, Process Development and Analytical Development to review/edit documentation such as batch records, methods, validation protocols and reports, and testing data.
• Lead the QA editing, review, and approval activities within the QMS (document and training management systems) related to controlled documentation creation/revision and training compliance.
• Provide Quality on the Floor support for manufacturing and laboratory operations.
• Review executed production and testing records to ensure compliance to company procedures, regulatory filings, and applicable regulations.
• Review and approve Quality System Records, including but not limited to Change Controls, Deviations, Out of Specification, Corrective and Preventative Actions, and Complaints.
• Assist in executing QA responsibilities to support material and product release.
• Responsible for report creation for metrics reporting/monitoring to support QA responsibilities/QMR.
• Represent Quality Assurance on project teams and in meetings.
• Support the continuous improvement and oversight of Quality Management System procedures.
• Assist colleagues' company-wide with understanding and adopting GMP / GDP practices in alignment with established procedures.
• Participate in internal audits in accordance with internal procedures for audit and inspection management.
• Actively participates in fostering a positive, collaborative work culture.
• Support other QA functions with other projects and tasks, where applicable.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. 

• BS or equivalent in life science or related field and 7+ years industry experience in manufacturing/testing (GMP) and/or clinical (GCP) Quality Assurance; or equivalent combination of education and experience.
• Knowledge of FDA regulations and standards, especially those pertaining to cell therapy, gene therapy, bioanalytical testing, and clinical research.
• Experience authoring, reviewing, and/or approving procedures, policies, work instructions, and any other related controlled documentation needed to support site requirements.
• Experience authoring, reviewing, and/or approving quality events such as deviations and laboratory investigations/OOS/OOT.
• Exceptional communication and interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges.
• Exceptional oral and written communication skills to all organization levels as well as clients and vendors.
• Strong organizational skills; able to prioritize and manage through complex processes/projects.
• Ability to be hands-on and detail orientated.
• Proficient in MS Office application suite as well GMP electronic applications such as QMS / LIMS
• Veeva document management and vault training manager experience preferred.
• Effectively manages cross-functional communication.
• Strong organizational skills; able to prioritize and manage through complex processes/projects.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to work independently and stay on task in a fast-paced environment.

Travel Requirements

• This position will be expected to travel to all applicable locations as needed. 

 Location

• This is a site-based position in Research Triangle Park, NC, and it will require some non-standard working hours, including early morning or late evening.

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